FDA Warning Letter - Consent Decree Software Validation
Duration: 60 Minutes
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This training on FDA software validation related warning letters will discuss what to do to avoid additional software related compliance issues along with the response steps where the citations directly or indirectly include automated system.
01/11/2017 10:00 AMTraining Topic: FDA Warning Letter - Consent Decree Software ValidationInstructor: Alfonso Fuller
Objectives of the Presentation
Outline of FDA regulations as applied to software
Review of FDA software validation requirements
Review of FDA software expectations
Proactive steps to prevent additional software-related compliance and enforcement problems
Response steps where inspection citations directly or indirectly include automated systems
What to do about existing systems
The paradox of ongoing validation work
Why should you Attend
FDA inspectors are now being trained to evaluate software validation practices. Increasing use of automated manufacturing and quality systems have increased exposure. Most recalls can be traced back to computerized equipment, exposing the validation process to scrutiny. A third of recent warning letters included citations with respect to improper or ineffective validation. Computerized quality system tracking systems are subject to increased scrutiny during compliance and enforcement actions and hence incomplete software validations are ticking time bombs.
Once the FDA inspectors or Federal marshalls have arrived, it is time to set up an effective software validation and software quality program - even if those were not the original citations that brought you to FDA's attention. Attend this webinar if you have received, expect or fear an FDA-483, Warning Letter or Consent Decree. Learn steps that can be done proactively and forward plan to prevent additional software related compliance issues and how to prepare response where citations directly or indirectly include automated system.
Who will Benefit
This webinar will give valuable help to FDA regulated Pharmaceutical, Medical Device, Biotech, Diagnostics and Biological manufacturers who have received, expect or fear an FDA-483, Warning Letter or Consent Decree. The staff members who will benefit include:
Quality Assurance Personnel and Management
SQA - Software Quality Personnel
Business Managers Responsible for System Compliance
IT / IS Managers
Regulatory Affairs Personnel and Management
Third-Party Certifier Personnel
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